PENTASA Tablet Prolonged Release 500 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-05-2024
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Active ingredient:
MESALAZINE
Available from:
Profind Wholesale Ltd.
Dosage:
500 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
2010-06-04
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PPA1500/049/001
Case No: 2083450
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PROFIND WHOLESALE LTD.
UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
PENTASA 500MG PROLONGED-RELEASE TABLETS
the particulars of which are set out in the attached Schedule. The authorisation is also subject to the general conditions as may be specified in
the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 28/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/07/2010_
_CRN 2083450_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pentasa 500mg Prolonged-release Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains mesalazine 500 mg.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
_Product imported from Italy:_
White-grey to pale brown, speckled, round, prolonged release tablets, scored and marked '500mg' on one side and
'PENTASA' on the reverse side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of Ulcerative colitis and Crohn’s disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ULCERATIVE COLITIS_
_Adults:_
Acute treatment: Individual dosage of up to 4g mesalazine
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